510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890405Substantially Equivalent

Usci Pta Balloon Dilatation Catheter

C.R. Bard Inc, Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890405 is the FDA 510(k) clearance record for USCI PTA BALLOON DILATATION CATHETER, a class II device, cleared for C.R. Bard, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K890405.

Clearance record

Decision date
Received
(205 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 1200 Technology Park Dr., Billerica MA
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to November 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260
November 20260